Condition: Diabetic Neuropathy · Sponsor: University Medical Center Groningen
Rationale: Of all individuals with diabetes, 19-34% develop a foot ulcer in their lifetime, and nearly 25% of these ulcers result in amputation. Ulcer prevention is often addressed by prescribing orthopedic shoes (OS). However, the effectiveness of OS is highly dependent on the individual shoe technician's skill and experience, and OS is frequently perceived as unattractive by users. To overcome these limitations, the LEEF-shoe was developed. It eliminates the need for a fully individualized shoe technician approach by using a standardized protocol to determine the rocker settings. This may provide comparable plantar pressure relief, while potentially improving patient acceptance due to its more appealing design and simplified prescription process. Objective: The primary objective is to determine whether the LEEF-shoe differs from standard-OS in terms of plantar pressure distribution. Secondary objectives are evaluation of wearing time and user acceptance of both footwear types. Study design: This study is a randomized cross-over trial. Participants will complete pre- and post-tests for plantar pressure distribution, wearing time will be measured, and focus group sessions will assess user experience and acceptance. Study population: A total of 30 adults (≥18 years old) with diabetes mellitus and peripheral neuropathy, at increased risk for foot ulceration, will be included. Intervention: All participants will receive two pairs of OS, a standard-OS and an additional OS (…
This description comes directly from the study's public registry record.
Jelmer Braaksma, PhD · +31 6 24665798 · j.braaksma01@umcg.nl
Juha M Hijmans, PhD · +31 (0)6 55256225 · j.m.hijmans@umcg.nl
Always discuss trial participation with your own doctor first.
| University Medical Center Groningen | Groningen, Provincie Groningen, Netherlands | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07488104